Lupus drug belimumab (Benlysta) data highly promising: GSK, Human Genome Sciences

No new drug for lupus has been approved in more than 50 years

Belimumab (Benlysta) an investigational drug to treat lupus developed by GlaxoSmithkline and  Human Genome Sciences, Inc has been found safe and effective in patients with  systemic lupus erythematosus (SLE).

Belimumab plus standard of care achieved a clinically and statistically significant improvement in patient response rate as measured in systemic lupus erythematosus (SLE) Responder Index at Week 52, compared with placebo plus standard of care, Glaxo and HGS reported.

Belimumab (Benlysta) data were generated from two pivotal Phase 3 trials in seropositive patients with systemic lupus erythematosus (SLE) titled Bliss-52.

Glaxo and HGS presented the data at the 73rd Annual Scientific Meeting of the American College of Rheumatology (ACR),in Philadelphia.

Study results also showed that belimumab was generally well tolerated, with adverse event rates comparable between belimumab and placebo treatment groups.

“These data were statistically significant and were strongly supported across multiple measures of clinical effect and multiple time-points.  Of note, a greater percentage of patients receiving BENLYSTA were able to reduce their use of steroids,” stated David C. Stump, M.D., Executive Vice President, Research and Development, HGS in a press release.

Belimumab is a human monoclonal antibody drug that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator, or BLyS.

BLyS is a naturally occurring protein discovered by HGS that is required for the development of B-lymphocyte cells into mature plasma B cells. Plasma B cells produce antibodies, the body’s first line of defense against infection.

In lupus and certain other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies – antibodies that attack and destroy the body’s own healthy tissues. The presence of autoantibodies appears to correlate with disease severity.

Belimumab is being developed by HGS and GSK under a co-development and commercialisation agreement entered into in August 2006. HGS has responsibility for conducting the belimumab Phase 3 trials, with assistance from GSK. The companies will share equally in Phase 3/4 development costs, sales and marketing expenses, and profits of any product commercialized under the current agreement.

Results from BLISS-76, the second Phase 3 trial of belimumab, will be announced on 02 November 2009.

HGS and GSK plan to submit marketing applications in the United States, Europe and other regions in the first half of 2010.
Belimumab has also significantly delayed time to first SLE disease flare versus placebo.

In patients who were receiving prednisone, their average prednisone dose reduced by at least 25% from baseline.

The Phase 3 development programme for belimumab includes two double-blind, placebo-controlled, multi-centre Phase 3 superiority trials – BLISS-52 and BLISS-76 – to evaluate the efficacy and safety of belimumab plus standard of care.

This is the largest clinical trial programme ever conducted in lupus patients.  BLISS-52 randomised and treated 865 patients at 90 clinical sites in 13 countries, primarily in Asia, South America and Eastern Europe.

BLISS-76 enrolled and randomised 826 patients at 133 clinical sites in 19 countries, primarily in North America and Europe.  The design of the two trials is similar, but the duration of therapy in the two studies is different – 52 weeks for BLISS-52 and 76 weeks for BLISS-76.

Systemic Lupus Erythematosus

Systemic lupus erythematosus (SLE) is a chronic, life-threatening autoimmune disease. Approximately five million people worldwide, including approximately 1.5 million in the United States, suffer from various forms of lupus, including SLE.

Lupus can occur at any age, but appears mostly in young people ages 15 to 45. About 90 percent of those diagnosed with lupus are women. African-American women are about three times more likely to develop lupus, and it is also more common in Hispanic, Asian and American Indian women.

Symptoms of lupus include extreme fatigue, painful and swollen joints, unexplained fever, skin rash and kidney problems.

Lupus can lead to arthritis, kidney failure, heart and lung inflammation, central nervous system abnormalities, inflammation of the blood vessels and blood disorders.

No new drug for lupus has been approved by regulatory authorities in more than 50 years.

Human Genome Sciences has a clinical development pipeline including novel drugs to treat hepatitis C, lupus, inhalation anthrax and cancer.Apart from Benlysta (belimumab) for lupus, HGS has Zablin (albinterferon alfa-2b, formerly Albuferon) for hepatitis C.  Zalbin has now completed Phase 3 development, and the submission of global marketing applications is expected in late fall 2009.  In May 2009, HGS submitted a Biologics License Application to the FDA for raxibacumab for the treatment of inhalation anthrax.  In addition, HGS has substantial financial rights to certain products in the GSK clinical pipeline including darapladib, currently in Phase 3 development in patients with coronary heart disease, and Syncria (albiglutide), currently in Phase 3 development in patients with type 2 diabetes.

GSK is one of the world’s leading research-based pharmaceutical and healthcare companies.